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Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
This study is currently recruiting participants.
Study NCT00560222   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: November 15, 2007   Last Updated: May 27, 2008   History of Changes

November 15, 2007
May 27, 2008
February 2008
April 2011   (final data collection date for primary outcome measure)
Determination of the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Determination of the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 12 month trial in previously weaned Peruvian children enrolled at 12 to 24 months of age. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00560222 on ClinicalTrials.gov Archive Site
Determination of the effect of bovine lactoferrin supplementation on growth. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Determination of the effect of bovine lactoferrin supplementation on growth. [ Time Frame: 6 months ]
 
Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

Much has been learned in recent years about the mechanisms by which breastfeeding improves child health and survival. However, there has been little progress in using these insights to improve pediatric care. Factors that are important for protecting the breast fed infant might be expected to decrease the adverse effects of weaning on diarrhea, growth, and development. The proposed study is meant to begin addressing this important gap by a clinical trial of lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those consumed if the child were still breastfed) will improve health by mimicking its protective roles in milk. The significance of these studies is that they will prove feasibility of improving child health after the end of breastfeeding by continuing ingestion of a major protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may be amenable to this approach.

The proposed community-based study will be conducted in a previously weaned population at risk for repeated intestinal infections. Infants who are 12-18 months of age living in the District of Independencia, Lima, Peru will be eligible for enrollment. We will conduct a randomized double blind placebo controlled trial comparing twice daily supplementation with bovine lactoferrin versus a placebo (maltodextrin) Therapy will be continued for 6 months with close monitoring of all study participants for diarrhea and growth.

Specific aim 1: Determine the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age.

Specific aim 2: Determine the effect of bovine lactoferrin supplementation on growth.

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Diarrhea
  • Malnutrition
  • Dietary Supplement: bovine lactoferrin
  • Dietary Supplement: placebo [maltodextrin]
  • Active Comparator: This group will receive daily lactoferrin supplementation
  • Placebo Comparator: placebo

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
602
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Infants 12 to 18 months of age from the Outpatient clinics (Puestos de Salud) of Districto de Independencia in Lima, Peru will be eligible for enrollment in this study.
  2. Infants previously weaned for at least one week will be eligible for study.

Exclusion Criteria:

  1. Infants with either exclusive or partial breast-feeding will not be enrolled; mothers will be encouraged to continue breastfeeding.
  2. Infants ill with severe, persistent or chronic diarrhea will be excluded.
  3. Infants with severe malnutrition (defined as weight-for-height < -3 SDs, height-for-age < -3SDs)will be excluded.
  4. Infants with a serious infections that required hospitalization 1 month prior (e.g. meningitis,pneumonia, bacteremia) will be excluded.
  5. Infants with known HIV (data from parent or medical records) will be excluded.
  6. Infants with underlying chronic illness (e.g. malignancy, immunosuppression, chronic renal failure, congestive heart failure, liver failure) will be excluded.
  7. Infants with history of allergy to cow's milk or infant formula, eczema, allergic rhinitis or asthma will be excluded.
  8. Infants with a family history of eczema, allergic rhinitis, asthma, or milk intolerance will be excluded.
Both
12 Months to 18 Months
Yes
Contact: Thomas G Cleary, MD 713 702 2860 thomas.g.cleary@uth.tmc.edu
Contact: Theresa J Ochoa, MD theresa.j.ochoa@uth.tmc.edu
Peru
 
NCT00560222
Thomas Cleary/Professor, University of Texas School of Public Health
1 R01 HD051716-01A2, 1 R01 HD051716-01A2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Thomas G Cleary, MD University of Texas School of Public Health - Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP